BMJ Open (Jun 2024)
Association of perioperative glucose profiles assessed by continuous glucose monitoring (CGM) with prognosis in Chinese patients with non-ST-elevation acute coronary syndrome: a cohort study protocol
Abstract
Introduction Non-ST-elevation acute coronary syndrome (NSTE-ACS) remains a significant clinical concern, accounting for over 70% of acute coronary syndrome cases. One well-established risk factor for NSTE-ACS is abnormal glucose metabolism, which is associated with a poor prognosis postpercutaneous coronary intervention. Effective monitoring of blood glucose is crucial in diabetes care, as it helps identify glucose metabolic imbalances, thereby guiding therapeutic strategies and assessing treatment efficacy. Continuous glucose monitoring (CGM) provides comprehensive glucose profiles. Therefore, the study aims to use CGM to track perioperative glucose variations in NSTE-ACS patients and to determine its prognostic implications.Methods and analysis This is a multicentre, prospective observational study in a sample of patients (aged >18 years) with NSTE-ACS. A total of 1200 eligible patients will be recruited within 1 year at 6 sites in China. The primary composite endpoint will be determined as major adverse cardiovascular events (MACE) at 3 years. MACE includes all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and target vessel revascularisation. Employing the CGM system, glucose levels will be continuously monitored throughout the perioperative phase. Prespecified cardiovascular analyses included analyses of the components of this composite and outcomes according to CGM-derived glucometrics at baseline.Ethics and dissemination This study has received approval from the Medical Research Ethics Committee of The First Affiliated Hospital of the University of Science and Technology of China (No. 2022KY357) and will adhere to the moral, ethical and scientific principles outlined in the Declaration of Helsinki. All participants will provide written informed consent prior to any study-related procedures. Findings from the study will be shared at conferences and published in peer-reviewed scientific journals.Trial registration number ChiCT2300069663.